COVID-19 Guidance
Refer to the following for general information and guidance on COVID-19:
- Important Therapeutic Goods Administration (TGA) Medicines Shortage Advice regarding intravenous Tocilizumab (Actemra) in clinical trial settings.
- Clinical Trials Project Reference Group (CTPRG) national guidance: COVID-19 Guidance on clinical trials for institutions, HRECs, researchers and sponsors
- Combined industry guidance: Joint Position Statement from Research & Development Taskforce (RDTF) – Supporting Clinical Trials during the COVID-19 pandemic
- NHMRC COVID-19 impact statement
Victorian HREC Research Managers COVID-19 statement:
"In response to the unprecedented COVID-19 pandemic, Hospital Research Ethics & Governance Offices across Victoria are working to ensure that ethics and governance reviews of COVID-19 related clinical trials and health research projects are encouraged, supported and expedited to meet these challenging times.
We ask for patience, flexibility and creativity from all stakeholders as we work together to accelerate research during this rapidly evolving healthcare emergency.
The Hospital Research Managers Sub-Committee is supported by the Melbourne Academic Centre for Health, Monash Partners and Western Alliance."
Please contact Monash Partners Academic Health Science Centre on 03 8572 2637 for further information regarding Victorian HRECs.
Refer to the Victorian hospital Research Office for contact details.
PICF for future Coronavirus or related research
A PICF template is available for the collection of health information and samples for future Coronavirus or related research. Information in the PICF refers to Victorian legislation. If using this PICF under NMA it will be necessary for other jurisdictions to insert specific legislation (if applicable) for health information and samples.
Refer to the following table for details.
Streamline e-Bulletin
This communication is open to all stakeholders in research and clinical trials sectors. Email us to register for the Streamline eBulletin: multisite.ethics@safercare.vic.gov.au
Past Streamline e-Bulletins
- Streamline eBulletin, November 2024
- Streamline eBulletin, October 2024
- Streamline eBulletin, September 2024
- Streamline eBulletin, August 2024
- Streamline eBulletin, July 2024
Events
National Clinical Trials Governance Framework
Learnings from 2023. 06 February 2024
Australian Teletrial Program-Victoria (ATP-VIC)
Teletrials - Ethics, site governance and startup - 21 July 2023
- Suzanne Hasthorpe - Overview of ATP and setting the scene
- Michelle Tamplin and Nicoline Wedemeyer – Sponsor perspective
- Nicole Humphreys – Teletrials - A Regional Experience
- Anne Woollett – Teletrials - The primary site perspective
- Angela Henjak - HREC expectations when reviewing teletrials & case studies
Past annual May conferences
Annual May conference presentations – 01 May 2019
Streamlining Clinical Trials and Research: 10 Years in Victoria
- Lucas Litewka and Nicole Bechaz – Clinical Trials in a Primary Care Setting – A perspective based on the University of the Sunshine Coast Clinical Trials Centre (USC CTC) experience
- Martin Delatycki – Translating Research – the Experience of a Clinical Researcher
- David Ball – CHISEL (TROG 09.02); A Randomised Phase III Trial of Stereotactic Ablative Radiotherapy v Standard Radiotherapy for Stage I Non-small Cell Lung Cancer
- Dr Ieva Ozolins and Dr Katherine Clark – Clinical Trials and Biologicals
- Sabe Sabesan – Teletrial Implementation: Interplay between Clinics and Policy
- Melissa Hagan – How Queensland Health Operationalised the Teletrials Vision
- Suzanne Hasthorpe – National Mutual Acceptance and Teletrials Policy Development
Annual May conference presentations - 2 May 2018
Research Landscape - Advances and Changes
- Chantal Gebbie and David Speakman – Clinical Trial Access for Regional, Rural and Rare Cancer Patients using Telehealth - The Australasian Tele-trial Model
- Kym Short – eConsent – Where Are We Now?
- Mary Hayek – Neuroscience: What’s the Difference?
- Simon Barrett – The Paperless Committee
- Suzanne Hasthorpe – Early Phase Clinical Trials: A Toolkit for Expert Scientific Review
National mutual acceptance symposium
- James Cokayne Presentation
- Suzanne Hasthorpe Presentation
- Melissa Hagan Presentation
- Catherine Bourgeois Presentation
- Rebecca Nuhiu Presentation
- Kym Short Presentation
- Jaspreet Sidhu Presentation
Contact us
Contact the Coordinating Office for Clinical Trial Research:
- Email: multisite.ethics@safercare.vic.gov.au
- Phone: 0408 274 054 - General enquiries and ERM application advice
- Phone: 0408 410 938 - Enquiries and ERM for Research Office administrators
9am – 5pm AET, Monday – Friday